- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06584487
Proximal Metatarsal Osteotomy in Correction of Hallux Valgus
Proximal Metatarsal Medial Opening Wedge Osteotomy Fixed by Plate and Screws in Correction of Hallux Valgus
Study Overview
Status
Conditions
Detailed Description
Hallux valgus is a common cause of foot pain and deformity in the adult and adolescent population, which often requires surgical treatment when nonsurgical treatments fail.
During the past decades, multiple modified procedures and fixation techniques have been described.
The most common types of osteotomies of the first metatarsal are crescentic, chevron, scarf and lateral or medial opening wedge techniques.
A concern with the Chevron and other distal osteotomies is the development of avascular necrosis of the first metatarsal head with a reported incidence of between 0% and 20%.
On the other side, the proximal dome osteotomy along with a distal soft tissue release is an excellent procedure. The proximal location of the osteotomy avoids devascularization of the metatarsal head, and the crescent shape maintains the length of the metatarsal. It allows a high degree of correction at the intermetatarsal angle in severe deformities.
When the condition is associated with an increased intermetatarsal angle, a surgical technique using a proximal first metatarsal osteotomy is often indicated. A proximal opening wedge osteotomy stabilized with a wedge and plate configuration offers a stable, reliable means to correct the increased intermetatarsal angle.
Over the past 10 years, some surgeons have increasingly used locking plates instead of a single screw for stabilisation of the osteotomy with the assumption of better postoperative stability and preserved length of the first metatarsal. In addition, fixation with a plate has been described as technically less challenging.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Abdulrahman M Hussein Mohamed, Master
- Phone Number: +2001063555610
- Email: Abd-Elrahman.20134151@med.aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- all admitted patients to Assiut University Hospitals.
- age group of 15 years old and above.
- Moderate and severe degrees of hallux valgus.
Exclusion Criteria:
- Burn
- age group below 15 years old.
- patient who refuse to participate in the study.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The American Orthopedic Foot and Ankle Society hallux-metatarsophalangeal-interphalangeal scale (AOFAS scale).
Time Frame: baseline
|
Pain-Function-Alignment
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post operative radiographic changes in standing AP view foot and standing lateral view foot.
Time Frame: Baseline
|
In standing AP view foot
|
Baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Robinson AH, Limbers JP. Modern concepts in the treatment of hallux valgus. J Bone Joint Surg Br. 2005 Aug;87(8):1038-45. doi: 10.1302/0301-620X.87B8.16467. No abstract available.
- Markbreiter LA, Thompson FM. Proximal metatarsal osteotomy in hallux valgus correction: a comparison of crescentic and chevron procedures. Foot Ankle Int. 1997 Feb;18(2):71-6. doi: 10.1177/107110079701800205.
- Saragas NP. Proximal opening-wedge osteotomy of the first metatarsal for hallux valgus using a low profile plate. Foot Ankle Int. 2009 Oct;30(10):976-80. doi: 10.3113/FAI.2009.0976.
- Okuda R, Kinoshita M, Yasuda T, Jotoku T, Shima H. Proximal metatarsal osteotomy for hallux valgus: comparison of outcome for moderate and severe deformities. Foot Ankle Int. 2008 Jul;29(7):664-70. doi: 10.3113/FAI.2008.0664.
- Thordarson DB, Leventen EO. Hallux valgus correction with proximal metatarsal osteotomy: two-year follow-up. Foot Ankle. 1992 Jul-Aug;13(6):321-6. doi: 10.1177/107110079201300605.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hallux valgus osteotomy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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